Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression

Lumbar Disc Prolapse With Radiculopathy Clinical Trial

Official title: Temporary Axial Rotation Stabilization for Lumbar Disc Prolapse Surgery With the ARO® Spinal System: A Non-randomized Prospective Analysis of Clinical Efficacy, Safety and Cost Effectiveness

Status Active, not recruiting

Clinical Trial Summary

To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations.

The general hypothesis is that the ARO significantly improves outcomes in patients undergoing decompression surgery for symptomatic lumbar disc herniations.

Clinical Trial Description

Not provided ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Prolapse With Radiculopathy
• Prolapse
• Radiculopathy

• NCT number: NCT01970514
• Study type: Interventional
• Source: ARO Medical
• Status: Active, not recruiting
• Phase: Phase 0
• Start date: April 2012
• Completion date: July 2015